Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 6, 2024

MARIZYME, INC.

(Exact name of registrant as specified in its charter)

Nevada

000-53223

82-5464863

(State or other jurisdiction
of incorporation)

(Commission

File Number)

(IRS Employer
Identification No.)

555 Heritage Drive, Suite 205, Jupiter, Florida		33458
(Address of principal executive offices)		(Zip Code)

(561) 935-9955

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

	☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

	☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

	☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

	☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

☐

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Not applicable.

Item 7.01. Regulation FD Disclosure.

On May 6, 2024, Marizyme, Inc. (the “Company”) issued a press release announcing that it had received 510(k) clearance from the U.S. Food and Drug Administration for controlled room temperature storage of its flagship product DuraGraft. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information furnished pursuant to this Item 7.01 (including Exhibit 99.1 hereto), shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act, except as expressly set forth by specific reference in such a filing.

Forward-Looking Statements

The press release and the statements contained therein include “forward-looking” statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. In some cases, you can identify these statements because they contain words such as “may,” “will,” “believes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “should,” “seeks,” “future,” “continue,” “plan,” “target,” “predict,” “potential,” or the negative of such terms, or other comparable terminology that concern the Company’s expectations, strategy, plans, or intentions. Forward-looking statements relating to expectations about future results or events are based upon information available to the Company as of today’s date and are not guarantees of the future performance of the Company, and actual results may vary materially from the results and expectations discussed. Forward-looking statements include, but are not limited to, the Company’s expectations regarding its plan for U.S. commercialization of DuraGraft™, the potential for DuraGraft™ to be used in cardiac care delivery services, its financial position and operating performance, its expectations regarding its business strategy, its business initiatives, its operating performance, trends in its business, the effectiveness of its growth strategy, its market opportunity, and demand for its products and services in general. The Company’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. All subsequent written and oral forward-looking statements concerning the Company or other matters and attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. The Company does not undertake any obligation to publicly update any of these forward-looking statements to reflect events or circumstances that may arise after the date hereof, except as required by law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description of Exhibit
99.1		Press Release dated May 6, 2024

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, Marizyme, Inc. has duly caused this current report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: May 6, 2024	MARIZYME, INC.

	By:	/s/ David Barthel
		David Barthel
		Chief Executive Officer

Exhibit 99.1

Marizyme, Inc. Secures FDA 510(k) Clearance for Controlled Room Temperature storage DuraGraft^®

Jupiter, FL, May 6, 2024 — Marizyme, Inc. (OTCQB: MRZM) is pleased to announce that its flagship product DuraGraft will no longer require refrigerated storage and will be able to be stored at controlled room temperatures of 20^oC-25^oC allowing it to be stocked directly on shelves in the Operating Room instead of the hospital pharmacy.

The change to the labeled storage temperature for US marketed product, cleared by the FDA through a 510(k) premarket notification pathway, presents significant advantages; the primary being that DuraGraft no longer requires storage in hospital pharmacy refrigerators. Pharmacy products are not readily available to the surgeon and must be ordered prior to surgery, presenting not only an inconvenience to the surgeon but also an additional step that may cause delays in initiating time-critical surgical procedures. For these reasons, a surgeon may not always opt to use DuraGraft. By making DuraGraft readily available in the operating suite, it can more easily and quickly be integrated into surgical procedures thereby driving adoption and increasing utilization.

Controlled room temperature storage of product also provides substantial logistics and cost saving advantages related to product warehousing and distribution as the product no longer requires cold warehouse storage and shipping, providing significant cost savings that are passed off to distributors and end users. Additionally, product can now be sold directly though hospital procurement channels as opposed to the more challenging hospital pharmacy pathway.

“We believe this FDA 510(k) clearance provides substantial advantages to the surgeon, patient and supply chain of the product and supports our commitment to improving patient outcomes in cardiac surgery,” said David Barthel, CEO of Marizyme, Inc.

About DuraGraft

DuraGraft is the first and only FDA authorized product intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours in adult patients undergoing Coronary Artery Bypass Grafting (CABG), surgeries. The labelled mechanism of action is the reduction of oxidative damage to maintain the structural and functional integrity of vascular conduits.CABG is the most common type of open-heart surgery in the United States with more than 500,000 surgeries performed each year.

About Marizyme

Marizyme, Inc. is a medical technology company changing the landscape of cardiac and surgical care by delivering innovative solutions for coronary artery bypass graft (CABG) surgery and other surgical procedures. Marizyme’s first in-class product, DuraGraft, was granted a De Novo on October 4, 2023, from the U.S. Food and Drug Administration (FDA). With its CE Mark, DuraGraft continues to drive sales growth internationally in Europe and Asia and will now target the U.S. market to further drive utilization and sales.

For more information about Marizyme, please visit www.marizyme.com.

Forward-Looking Statements

This news release contains forward-looking statements by Marizyme (the “Company”) that involve risks and uncertainties and reflect the Companies’ judgment as of the date of this release. These statements include those related to the Companies’ prospects and strategy for development of the Companies’ medical devices amongst others. Actual events or results may differ materially from the Companies’ expectations. The Companies’ stock prices could be harmed if any of the events or trends contemplated by the forward-looking statements fail to occur or is delayed or if any actual future event otherwise differs from expectations. Potential risks include, not are not limited to, the failure of Marizyme to fully commercialize its products, failure to properly price or market the products in the United States, the need for additional funding to complete studies, manufacturing and other important tasks to sell the products, safety concerns with the use of the product, regulatory delays, and other similar risks. Additional information concerning these and other risk factors affecting each of the Company’s business can be found in the Company’s prior filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, all of which are available at www.sec.gov.

The Companies disclaim any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Harrison Ross, Marizyme, Inc.

561-433-6626

Hross@marizyme.com

Cover	May 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 06, 2024
Entity File Number	000-53223
Entity Registrant Name	MARIZYME, INC.
Entity Central Index Key	0001413754
Entity Tax Identification Number	82-5464863
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	555 Heritage Drive
Entity Address, Address Line Two	Suite 205
Entity Address, City or Town	Jupiter
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33458
City Area Code	561
Local Phone Number	935-9955
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false